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A phase I study of the fully human, fragment crystallizable-engineered, anti-CD-33 monoclonal antibody BI 836858 in patients with previously-treated acute myeloid leukemia.

作者信息

Vasu Sumithira, Altman Jessica K, Uy Geoffrey L, Tallman Martin S, Gojo Ivana, Lozanski Gerard, Burkard Ute, Osswald Annika, James Pamela, Rüter Björn, Blum William

机构信息

Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, OH.

Division of Hematology/Oncology, Northwestern University, Chicago, Illinois.

出版信息

Haematologica. 2022 Mar 1;107(3):770-773. doi: 10.3324/haematol.2020.274118.

DOI:10.3324/haematol.2020.274118
PMID:34854276
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8883544/
Abstract
摘要

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A phase I study of the fully human, fragment crystallizable-engineered, anti-CD-33 monoclonal antibody BI 836858 in patients with previously-treated acute myeloid leukemia.一项针对曾接受治疗的急性髓系白血病患者的I期研究，该研究使用的是完全人源化、可结晶片段工程化的抗CD-33单克隆抗体BI 836858。
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Antibody Therapies for Acute Myeloid Leukemia: Unconjugated, Toxin-Conjugated, Radio-Conjugated and Multivalent Formats.急性髓系白血病的抗体疗法：非共轭、毒素共轭、放射性共轭及多价形式
J Clin Med. 2019 Aug 20;8(8):1261. doi: 10.3390/jcm8081261.
2
Investigational CD33-targeted therapeutics for acute myeloid leukemia.针对急性髓细胞白血病的 CD33 靶向治疗药物的研究。
Expert Opin Investig Drugs. 2018 Apr;27(4):339-348. doi: 10.1080/13543784.2018.1452911. Epub 2018 Mar 15.
3
Decitabine enhances anti-CD33 monoclonal antibody BI 836858-mediated natural killer ADCC against AML blasts.
用于治疗急性髓系白血病的抗体疗法：探索当前和新兴的治疗靶点。
Expert Opin Investig Drugs. 2023 Feb;32(2):107-125. doi: 10.1080/13543784.2023.2179482. Epub 2023 Feb 26.
4
An open-label, phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858, an unconjugated anti-CD33 monoclonal antibody, in combination with decitabine in patients with acute myeloid leukemia.一项开放标签的I/II期试验，旨在确定未偶联的抗CD33单克隆抗体BI 836858与地西他滨联合使用治疗急性髓系白血病患者的最大耐受剂量，并研究其安全性、药代动力学和疗效。
Haematologica. 2022 Dec 1;107(12):2977-2982. doi: 10.3324/haematol.2022.281128.
5
A phase I/II multicenter, open-label, dose escalation and randomized trial of BI 836858 in patients with low- or intermediate-1-risk myelodysplastic syndrome.一项关于BI 836858治疗低危或中危1型骨髓增生异常综合征患者的I/II期多中心、开放标签、剂量递增及随机试验。
Haematologica. 2022 Nov 1;107(11):2742-2747. doi: 10.3324/haematol.2021.280500.
6
Using stroma-anchoring cytokines to augment ADCC: a phase 1 trial of F16IL2 and BI 836858 for posttransplant AML relapse.使用基质锚定细胞因子增强 ADCC：F16IL2 和 BI 836858 治疗移植后 AML 复发的 1 期试验。
Blood Adv. 2022 Jun 28;6(12):3684-3696. doi: 10.1182/bloodadvances.2021006909.
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Haematologica. 2013 Feb;98(2):217-21. doi: 10.3324/haematol.2012.071092. Epub 2012 Aug 8.
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